Director, CMC (Chemistry Manufacturing and Control)
Allucent, Estonia

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light.When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

The Director, CMC is responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products. Responsibilities may include analysis/review of drug substance synthesis, pre-formulation and formulation evaluation, analysis of manufacture, scale-up and process validation, providing support of analytical methods development and validation, and evaluation of packaging and labeling components. The Director, CMC leads and/or participates in Health Authority (HA) communications including correspondences, teleconferences, and meetings. The Director, CMC reviews, provides advice on, or authors CMC-related regulatory content for HA submissions, reports, protocols, and other scientific documents.

Location: Central/Eastern Europe (Serbia, Romania, Estonia, Hungary, Poland, Czech Republic)

Workplace: hybrid/fully remote options possible

Experience: 6-10 years in Pharmaceutical / Clinical Research Industry

Language: Fluent in English

The Director, CMC will be responsible for the following tasks:

CMC Responsibilities

• Reviews and/or writes regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought
• Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development
• Guides the writing of regulatory/scientific documents written by other project team members
• Has advanced scientific knowledge of HA Regulatory Guidance and Regulations
• Interacts with various HAs, including leading HA meetings and participating as a subject matter expert; assists in preparation of meeting and briefing documents, and preparing responses to inquiries
• Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development issues with primary emphasis on scientific aspects
• Has advanced understanding of electronic common technical document (eCTD) format and requirements of regulatory submissions
• Prepares product development plans and/or strategies from early development through Phase 4
• Provides strategic advice in evaluating impact and necessary filing requirements and strategies for drug product post-approval changes/variations
• May provide expertise in GMP and GLP audits, inspection readiness and remediation activities
• Participates in meetings with clients and leads discussions in scientific area(s) of expertise as subject matter expert

Management, Learning amp; Development

• Director with direct line reports:
  • Provides training to direct reports on current and new regulatory requirements
  • Develops and presents internal and sponsor training
  • Actively manages direct reports including development and performance management
  • Tracks line report utilization and capacity
  • Coaches, mentors, and develops reports on collaborative consulting
• Director with or without direct line reports:
  • Actively supports staff learning amp; development within the company
  • Provides guidance and advises Project Leads, and/or Project Teams
  • Adherence to project budgets and contracts including scope and scope changes, timeline deliverables and active management of resources
  • Manages projects as a Consulting Technical Lead as assigned
  • Leads and/or participates in meetings with clients
  • Provides mentorship to team members
  • Acts professionally with peers and clients, knows business etiquette
  Business Development Responsibilities
• Assures good communication and relationships with clients<

Job Rewards and Benefits